padat preformulasi

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Teknologi Farmasi Sediaan Padat Pendahuluan Deni Rahmat

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PADAT PREFORMULASI

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Teknologi Farmasi Sediaan Padat

Teknologi Farmasi Sediaan PadatPendahuluan

Deni Rahmat

Obat : senyawa yang aktif secara fisiologi yang digunakan untuk pengobatan penyakit dalam manusia (Ansel).Senyawa obat mungkin didapat dari mineral, tumbuh-tumbuhan, binatang atau merupakan produk dari sintesis kimia organik atau biosisntesis.Senyawa obat dikombinasikan dengan bahan-bahan farmasetik tidak aktif secara fisiologi dalam penyiapan berbagai bentuk sediaan obat.

USP berisi monograpi yang detil tentang senyawa obat dan bentuk sediaan sementara National Formulary berisi monograpi mengenai bahan-bahan farmasetik.Harus dicatat bahwa banyak produk farmasetik di pasaran tidak dicantumkan dalam monograpi. Bentuk sediaan dari suatu obat mungkin bervariasi, dengan berbagai rute pemberiannya. Hal ini karena perbedaan rates and extents dari absorpsi dari berbagai cara pemberian obat.

Obat-obat yang diberikan secara intravena memasuki aliran darah secara langsung dan karenanya obat seluruhnya ada dalam darah.Pemberian secara oral mempunyai barriers biologi, kimia dan fisika. Dosis injeksi parenteral akan lebih rendah dibandingkan dengan dosis oral untuk mencapai konsentrasi obat dan efek terapi yang sama.

Absorpsi dapat terjadi di berbagai tempat di dalam tubuh yang dapat dicapai dari rektum, saluran cerna, di bawah lidah dan dari tempat-tempat lain. Karenanya, masing-masing obat harus dipelajari secara individual untuk menentukan rute terbaik dari pemberiannya dan selanjutnya bentuk sediaan yang sesuai untuk memenuhi persyaratan klinik yang diinginkan.Penakaran dosis pada sediaan cair adalah fleksibel dibandingkan dengan sediaan padat.

Obat-obat jarang diberikan sendiri tetapi bersama dengan satu atau lebih bahan pembantu yang mempunyai berbagai fungsi. Melalui penggunaan secara selektif bahan pembantu/eksipien/pharmaceutic ingredients bisa dihasilkan berbagai bentuk sediaan. Eksipien itu dapat : melarutkan, mensuspensikan, mengentalkan, mengencerkan, mengemulsikan, menstabilkan, mengawetkan, mewarnai, memberikan rasa kepada zat aktif.

Mengapa perlu dibuat bentuk sediaan?Penghantaran dosis yang akurat secara aman dan nyaman.Perlindungan zat aktif dari pengaruh yang merusak dari udara (oksigen) dan lembab. Perlindungan zat aktif dari pengaruh yang merusak dari asam lambung setelah pemberian oral. Menyembunyikan rasa yang tidak enak dari zat aktif (kapsul, tablet salut, sirup manis).

Menyediakan sediaan cair dari zat yang tidak larut atau tidak stabil dalam pembawa yang diinginkan (suspensi).Menyediakan bentuk sediaan cair yang larut dalam pembawa yang diinginkan (sirup).Menyediakan aksi obat yang diperpanjang melalui mekanisme controlled release (berbagai sediaan tablet, kapsul dan suspensi controlled release).

Menyediakan aksi obat yang optimal dari tempat pemberian secara topikal (salep, cream, patch transdermal, sediaan untuk diberikan di hidung, telinga dan mata).Menyediakan pemberian obat ke dalam celah di tubuh (suppositoria dan ovula).Menyediakan pemberian obat langsung ke dalam aliran darah (injeksi).Menyediakan aksi obat yang optimal melalui terapi inhalasi (inhalasi aerosol).

Rute Pemberian ObatOral |mulutSublingual|di bawah lidahParenteral|selain melalui saluran cerna (dengan injeksi)intravena|venaintraarteri|arteriintracardiac|hatisubkutan|di bawah kulit

intramuskular|ototTransdermal|permukaan kulitKonjungtival|konjungtivaIntranasal|hidungAural|telingaRektal|rektumVaginal|vaginaUretal|uretra

Bentuk Sediaan Padat:Oral|tablet, kapsul, serbukSublingual|tabletRektal|suppositoriaVaginal|suppositoria, tablet

PowderIn compounding, "powder" refers to a dosage formulation that is solid in physical state. But the formulation may be composed of only the active drug or may be a mixture of the active drug and other ingredients.

Pharmaceutical powders are formulated to be exist as fine particles. The powders are then smooth to the touch and nonirritating to the skin. Powders generally range from 0.1 to 10 micron in size. The size of the particles are often expressed as a number which corresponds to the mesh screen size of a sieve. The screen size indicates the number of openings in the mesh screen per inch. For example, a # 40 sieve has 40 openings per inch in the screen mesh. Particles that can sift through that mesh are said to be "40 mesh" size.

ComminutionReducing the particle size of a powder will result in an uniform distribution of particle sizes. The process of reducing the particle size is called comminution.

CapsuleThe word capsule is derived from the latin capsula meaning a small box.In pharmacy, the word capsule is used to describe an edible package made from gelatin which is filled with medicines to produce a unit dose, mainly for oral use. There are two types of capsule, differentiated by adjectives hard and soft.The hard capsule consists of two pieces, a cap and a body, that fit one inside the other.

They are produced empty and are filled in a separate operation.The soft gelatin capsule is a capsule which is manufactured and filled in one operation.The raw material used in manufacture are similar for both hard and soft capsules. The first stage of the process is to prepare a gelatine solution in demineralized water or a mixture of demineralized water and glyserol. To this are added, colorants, preservatives and process aid depending upon the type of capsule required.

TabletThe compressed tablet is the most popular dosage form in use today. About two-thirds of all prescriptions are dispensed as solid dosage forms, and half of these are compressed tablets. A tablet can be formulated to deliver an accurate dosage to a specific site; it is usually taken orally, but can be administered sublingually, rectally or intravaginally. It is just one of the many forms that an oral drug can take such as syrups, elixirs, suspensions, and emulsions. It consists of an active ingredient with biologically inert excipients in a compressed, solid form.

Tablets can be made in virtually any shape, although requirements of patients and tabletting machines mean that most are round, oval or capsule shaped. Tablet diameter and shape are determined a combination of a set of punches and a die. The thickness is determined by the amount of tablet material and the position of the punches in relation to each other during compression. Once this is done, we can measure the corresponding pressure applied during compression. The shorter the distance between the punches, thickness, the greater the pressure applied during compression, and sometimes the harder the tablet. Tablets need to be hard enough that they don't break up in the bottle, yet friable enough that they disintegrate in the gastric tract.

The tablet is composed of the Active Pharmaceutical Ingredient (that is the active drug) together with various excipients. These are biologically inert ingredients which either enhance the therapeutic effect or are necessary to construct the tablet. The filler or diluent (eg lactose or sorbitol) is a bulking agent, providing a quantity of material which can accurately be formed into a tablet. Binders (eg methyl cellulose or gelatin) hold the ingredients together so that they can form a tablet. Lubricants (eg magnesium stearate or polyethylene glycol) are added to reduce the friction between the tablet and the punches and dies so that the tablet compression and ejection processes are smooth. Disintegrants (eg starch or cellulose) are used to promote wetting and swelling of the tablet so that it breaks up in the gastro intestinal tract; this is necessary to ensure dissolution of the API. Additional ingredients may also be added such as coloring agents, flavoring agents, and coating agents.

Tableting methods consist of granulation and direct compression.Granulation may be defined as a size enlargement process which converts small particles into physically stronger & larger agglomerates.Granulation method can be broadly classified into two types: Wet granulation and Dry granulation.Powders that can be mixed well and therefore do no require granulation and can be compressed in to tablet through Direct Compression.

SuppositoriesSuppositories are solid preparations which may contain one or more active pharmaceutical ingredient(s) intended for rectal application. They are normally used for local action or systemic absorption of the active ingredient(s). They usually melt, soften, or dissolve at body temperature.Suppositories are usually prepared from excipients or bases such as cocoa butter, glycerinated gelatin and macrogols. They may also contain additives, such as adsorbents, surface-active agents, viscosity-influencing agents, antioxidants, antimicrobials, and authorized colouring agents.Any excipients used for the preparation of suppositories must be proven through product development studies not to affect adversely either the stability of the final product or the availability of the active ingredient(s) at the site of action; incompatibility between any of the components of the dosage form should be avoided.

OvulaVagina is route for administration for contraceptives, antifungals, antimicrobials.It is used for the achievement of local or for systemic absorption.The vaginal wall is very well suited for the absorption of drugs for systemic use.As it contains a vast network of blood vessels.